Accepted for/Published in: Interactive Journal of Medical Research
Date Submitted: Nov 1, 2023
Date Accepted: Apr 8, 2025
Impact of Fortified Malt-Based Food on Immunity Outcomes in School Children in India: Nutritional Epidemiology and Study Design for a Cluster Randomized Controlled Trial
ABSTRACT
Background:
Nutritional inadequacy and consequent diminished immunity among school age children is a public health problem in India. Nutrition interventional studies using cluster randomized controlled trial (RCT) design can avoid ethical issues inherent with double-blind individual RCT in children involving daily administration of empty-calorie placebo.
Objective:
We tested the hypothesis that daily administration of a fortified malt-based food (FMBF), a multi-nutrient supplement, would improve immunity outcomes against common infectious diseases, nutritional status and gut health in Indian school-age children, by utilizing cluster RCT design. This report presents the study design attributes and the baseline characteristics of the study population.
Methods:
This was an open-label, two-arm, parallel-group, matched-pair cluster RCT, stratified by gender, in children aged ≥7 to ≤10 years old with height-for-age Z-scores (HAZ) of ≥-3 to ≤-1 and good general health. Four schools located in Pune city in India participated in the study. Each school was deemed as a cluster and was randomized to test group (FMBF + dietary counseling) or control group (dietary counseling alone). A total of 924 participants from the 4 randomized schools were enrolled in the study.
Results:
Observed mean age ±SD was 8.0 years ±0.81 (range: min 7 years and max 10 years). There was no significant difference in mean age (p=.06), gender (p=.55), race (p=1), HAZ category (p=.051), HAZ (p=.17), BMI (p=.03). A very large proportion of children had micronutrient inadequacies in terms of vitamin D (97.51%), folate (79.18%), zinc (66.05%), and vitamin A (34.27%) at baseline. Design provided an operational ease of administration of study intervention at cluster level. Mean compliance with test product was 99.99% ( 95% CI) and retention in the study was observed 98% (95% CI).
Conclusions:
The findings highlight the extent of nutritional inadequacies in Indian school-age children, reaffirming the need for nutritional strategies to optimize the nutritional status among these children. Cluster RCT design can be effectively used in nutritional intervention trial in children by maintaining high compliance and retention in the study. Clinical Trial: Clinicaltrials.gov NCT02542865, https://clinicaltrials.gov/study/NCT02542865
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